Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device lower respiratory microbial nucleic acid detection system
Definition Device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens.
Product CodeQBH
Regulation Number 866.3985
Device Class 2


Premarket Reviews
ManufacturerDecision
CURETIS GMBH
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 BioFire Diagnostics, LLC II Feb-06-2024
2 BioFire Diagnostics, LLC II Aug-21-2023
3 BioFire Diagnostics, LLC II Jul-08-2021
4 BioFire Diagnostics, LLC II Jun-24-2021
-
-